Elective Induction vs Spontaneous Labour in Patients With Heart Disease
Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were randomised into elective induction and spontaneous labour groups only after bishop score was equal to or more than 6.It was concluded that induction of labour with oxytocin is a relatively safe procedure in women with low risk heart disease with NYHA class I and II. It resulted in a similar caesarean delivery rate and was not associated with more maternal and neonatal complications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL|
- Duration of labour [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]
- Rate of caesarean section [ Time Frame: at the time of delivery ] [ Designated as safety issue: Yes ]mode of delivery and rate of caesarean section with indication
- Number of patients with delivery during workday hours [ Time Frame: at the time of delivery ] [ Designated as safety issue: Yes ]
- number of patients with maternal complications [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
- number of patients with adverse neonatal outcome [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
|Study Start Date:||July 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: induction of labour
drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min
Arm - Induction of labour
No Intervention: Spontaneous Labour
patients were allowed to go into spontaneous labour
Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml normal saline was prepared and given through infusion pump at initial rate of 3mU/min. Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were established.
Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given intravenously for pain relief.